MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.

Reason: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

Code information: MOL3655 Simplexa VZV Swab Direct: Lot Numbers Release Date Exp Date 5743N 09/11/19 9/30/2020 5819N 10/09/19 10/31/2020 5820N 02/14/20 2/28/2021

Distribution pattern: Worldwide distribution - U.S. Nationwide distribution including in the states of CO, FL, KS, MI, NC, PA, TX, and WA The countries of Austria, Czech Republic, France and Switerland.